Saccharomyces Boulardii as Pretreatment Before Rescue Therapy of Helicobacter Pylori

NCT05191875 | Completed DMC

• 1 other identifier: xucanxia
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The increasing rate of drug resistance in often leads to eradication failure and the need for rescue therapy, and it is of great significance to explore new rescue therapeutic regimens. In this study, we observed the efficacy of rescue treatment of Helicobacter pylori (H.pylori) with Saccharomyces boulardii (S.boulardii) alone. the primary outcome of the trial was the eradication rate, and the secondary outcome was the incidence of adverse events.

Conditions

Helicobacter Pylori Infection

Keywords

Saccharomyces boulardii Helicobacter pylori rescue

Outcome Measures

Primary Outcomes (1)

• The eradication rate of H. pylori infection

  Evaluated by 13C-urea breath test (13C-UBT), or 14C-urea breath test (14C-UBT).

  Visit period 2 (day 42±3)

Secondary Outcomes (1)

• Adverse events

  Visit period 1 (day 14±1), Visit period 2 (day 28±1)

Study Arms (3)

group 1 of stage I

EXPERIMENTAL

14-day therapy：Saccharomyces boulardii. 500mg b.i.d

Drug: Saccharomyces Boulardii 250 MG

group 2 of stage I

NO INTERVENTION

Observe for one month before treatment

stage 2

OTHER

14-day therapy：Ilaprazole. 5mg b.i.d Doxycycline. 0.1g b.i.d Furazolidone. 0.1g b.i.d Colloidal Bismuth Tartrate . 220mg b.i.d

Drug: Ilaprazole.Doxycycline. Furazolidone. Colloidal Bismuth Tartrate

Interventions

Saccharomyces Boulardii 250 MG DRUG

Saccharomyces Boulardii: 0.25 g \* 6, Produced by The French encyclopedia pharmaceutical Factory

Also known as: treatment drugs of stage I

group 1 of stage I

Ilaprazole.Doxycycline. Furazolidone. Colloidal Bismuth Tartrate DRUG

Ilaprazole: 5mg\*6, produced by Livzon Pharmaceutical Group Inc Doxycycline: 0.1 g \* 10, produced by Jiangsu Yongxin Ltd. Furazolidone: 0.1g\*100 produced by Tianjin Lisheng Pharmaceutical Co., LTD Colloidal Bismuth Tartrate: 55 mg \* 36,produced by Shanxi Xinbaoyuan Pharmaceutical Co., LTD

Also known as: treatment drugs of stage II

stage 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 to 65 years, of either sex
• patients with a diagnosis of Hp infection
• patients who have failed treatment for Hp infection
• not taking acid-suppressing medications (PPI or H2 blockers) within the last 2 weeks
• who have not used antibiotics and/or bismuth within the last 4 weeks
• understand and are willing to participate in this clinical trial and provide a signed informed consent form.

You may not qualify if:

• those with a history of drug allergy
• those with severe cardiac, hepatic, pulmonary, and renal insufficiencies
• those with a recent history of gastrointestinal hemorrhage, obstruction, perforation, tumors, and other serious organic diseases of the gastrointestinal tract
• those with mental illness, psychological disorders that cannot be expressed normally
• those who are pregnant, lactating, or planning to have children in the near future during the study period.
• those who are not suitable for clinical trials and those who cannot cooperate

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: January 14, 2022
• Study Start: December 1, 2021
• Primary Completion: April 12, 2022
• Study Completion: April 23, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)